On January 27, Trevena Inc. (TRVN) declared the acceptance of NDA submission for oliceridine injection by China NMPA. Following the announcement, the stock became bullish in the premarket trading on Friday.
During regular trading, the stock fluctuated between a high of $0.5600 and a low of $0.4630. TRVN closed the session at $0.4800, with a loss of 5.40% on Thursday. Consequent to the announcement, the stock rebounded to gain 10.38% in the pre-market. Hence, TRVN was trading at $0.5298 per share at the last check on Friday.
Founded in 2009, Trevena Inc. works on novel medicines for central nervous system disorders. Currently, its 164.52 million outstanding shares trade at a market capitalization of $83.48 million.
NDA Application
Recently, TRVN’s partner Jiangsu Nhwa Pharmaceutical submitted New Drug Application for OLINVYK (oliceridine) injection with China NMPA. As per Thursday’s announcement, China’s National Medical Products Administrations (NMPA) has accepted the NDA submission.
Oliceridine is a novel IV analgesic approved by the U.S. FDA for acute pain management in adults.
Moreover, the NDA submission was based on data from two clinical bridging trials of OLINVYK in Chinese patients. The trials were designed to evaluate the safety profile, pharmacokinetics, and analgesic efficacy of OLINVYK.
In 2018, the company entered into an exclusive license with Nhwa for the development and commercialization of OLINVYK in China.
TRVN’s 2022 Participations
So far in 2022, the company’s President & CEO, Carrie Bourdow, and CFO, Barry Shin have participated in three conferences.
Firstly, LifeSci Partners 11th Annual Corporate Access Event & Panel Discussion from January 5-7, 2022.
Secondly, H.C. Wainwright BioConnect Virtual Conference from January 10-12, 2022.
Finally, BIO Partnering at JPM from January 10 to January 13, 2022.
TRV045 Clinical Development
On December 13, the TRVN announced the commencement of clinical development of TRV045. Following the FDA’s green signal, the company plans to commence A THREE-APRT Phase 1 MAD, food effect, and MAD trial. Furthermore, the study will evaluate the safety and tolerability of TRV045 along with its pharmacokinetics.
TRV045 is under development as a potential treatment for diabetic neuropathic pain (DNP).
In addition, the company is also assessing TRV045 for epilepsy under collaboration with the National Institute of Health.
TRVN’s Financials
In Q3 2021, the company incurred a net loss of $13.9 million ($0.08/share) against $5.6 million ($0.04/share) in Q3 of 2020.
Additionally, TRVN ended the third quarter of 2021, with cash and cash equivalents of $78.6 million on September 30, 2021.
